BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application

    FDA 510(k)
    FDA Class 2 ·Hematology

    ST AIA-PACK PROG II Calibrator Set

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE

    FDA 510(k)
    FDA Class 2 ·Microbiology

    VENACURE NEVERTOUCH

    FDA Adverse Event
    Malfunction ·ANGIODYNAMICS, INC.·Product code GEX·November 21, 2008

    THORATEC PVAD

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·September 11, 2011

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 23, 2013

    DISCARDIT II¿ SYRINGE WITH NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·May 15, 2018

    ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025